Title: Senior Research Associate 2, CoTe
Employee Type: FTE
Location: San Rafael, CA

SUMMARY

The Center of Technology (CoTe) is a centralized laboratory built around platform technologies and made available to scientists and physicians across Research and Development of BioMarin. The Mass Spectrometry (MS) Core withinthe CoTe provides collaboration, expert advice, service, training, and open access to state-of-the-art MS technologies to the entire scientific community of R&D.Our lab contains 15 mass spectrometers, including Orbitraps, QQQs, Q-Traps, and Q-TOFs (ESI + MALDI).

We are searching for a highly motivatedand experienced biological mass spectrometristto develop and implement LC/MS-based bioanalytical assays and workflows that will accelerate drug discovery and development at BioMarin.This position offers a unique career opportunity to work on the entire spectrum of a product lifecycle, from early drug discovery and non-clinical work through all stages of clinical development, including post-marketing work. The successful candidate will collaborate directly with colleagues from the CoTe, Research, and Translational Sciences to explore a diverse range of disease areas and treatment modalities. This person will be in a position to apply LC/MS-centric platformsto accelerate drug discovery and development, while maintaining a critical eye on assay quality and maintaining regulatory standards, when applicable.

RESPONSIBILITIES

• Develop analytical methods and workflows to quantifydrugs, metabolites and biomarkers in various biological matrices. Techniques may include (but are not limited to) mass spectrometry, HPLC/UPLC, micro-flow LC and nano-flow LC.
• Provide scientific oversight for outsourced assay transfer and validation, participate in audits and inspections, and adhere to regulatory compliance standards, when applicable.
• Develop new workflows, or bring in new technology from the outside, to enhance the analytical capabilities of the MS Core or CoTe, more broadly.
• Clearly and thoroughly document your work in your electronic notebook (Benchling).
• Present results, conclusions, and implications to Research and Translation Sciences clients and early development teams.
• Provide guidance and mentorship to junior lab staff and provide training/support to ‘open access’ users of the MS Core.
• Prepare SOPs and other documents such as assay development reports and data reports for testing results.
• Share responsibility for lab management and maintenance duties.
• Participate in scientific meetings and produce original peer-reviewed publications.

EDUCATION / EXPERIENCE

• A BS/MS with 8+ years of industry experience in biological mass spectrometry. Candidates with a Ph.D. in Biology, Chemistry or related field and a research emphasis on mass spectrometry applications plus 2+ years of industry experience using mass spectrometry and liquid chromatography in a bioanalytical fieldare also encouraged to apply.
• Strong analytical background with proficiency in developing and optimizing quantitative LCMS assays is required
• Experience with automating sample preparation, data collection and processing would be advantageous
• Experience with GLP and/or GCP-compliance and regulatory filing is a plus
• Demonstrated ability to work in a fast-paced, team-oriented environment with aggressive timelines
• Ability to interact successfully with team members from a wide variety of functional areas and diverse expertise levels.
• Publication record supporting a consistent contribution to successfully completed projects